Immunophenotype of PBMC to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma

ConditionLiver Cancer, Adult

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

The study is aimed to test the performance of a simple, easy, reproducible cytofluorimetric assay to complement imaging studies for:

* predicting response to immune-therapeutic regimens in HCC in the early phase of treatment, * to rule out pseudo-progression, * to early predict the escape from effectiveness of treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥ 18 years

diagnosis of HCC

execution of laboratory tests and subsequent treatments and follow-up at our center.

obtained written informed consent to the study participation

Disqualifiers

immune-related concomitant diseases

HIV infection

Trial population

patients with advanced hepatocellular carcinoma

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Immunochemotherapy combined with antiangiogenic
Drug
Immunochemotherapy combined with antiangiogenic

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: HCC patients1 intervention

Trial outcomes

Primary outcomes

To find predictive biomarkers of response to immunotherapy in HCC

Sensitivity and specificity of CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, TIGIT+, CD8+PD1+, CD8+PDL1+ peripheral lymphocytes and granulocytes for tumor response prediction according to RECIST 1.1 criteria

Time frame

at 3 month

Secondary outcomes

To compare the transcriptomic signatures of PBMC of responders and non-responders

Tumor response according to RECIST 1.1 criteria

Time frame

At 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor

Source ClinicalTrials.gov

Apply now